Everyone understands key business processes, their contribution to the processes, and process interactions.

Everyone actively participates in the management system.

Increased productivity from improved collaboration.

ISO 9001 Certification and Lean QMS® Facilitates Collaboration

Scripps Laboratories is a San Diego based manufacturer of proteins and immunoreagents. The company specializes in the sale of bulk quantities to the diagnostic industry and research facilities. For Scripps, the benefit of ISO 9001 certification was not a consideration. It was viewed as a necessary step to benefit business operations.

The company had previously implemented FDA 21 CFR 820 (QSR), a government requirement for an invitro diagnostic product which they no longer manufacture. So when competition and customer requirements directed them toward ISO 9001 certification, they began to work internally to implement the requirements, patterning the implementation after the FDA QSR program. In the case of Scripps Laboratories, the real business improvements are observed when comparing the company’s preconceptions and initial experiences in implementing ISO 9001 requirements (text based FDA QSR mode) to the quality system now used in daily operations.

Process and Documentation Misconceptions

Because of early misconceptions of “processes” vs. “tasks” within a process, Scripps tended to create excessive documentation. For their 400+ products they identified 60-70 unique processes. As a small operation with a lean workforce the effort required to document and maintain these processes was such an intrusion to the business that they elected to hire a full-time employee just to create the manuals and focus on the ISO certification project.

Even with this addition to the team, the ISO 9001 certification project and the materials created remained disconnected from the business. “We kept hitting roadblocks,” states Gabriele Noll, a senior team member who is responsible for purchasing. “Our purchasing process was an aggregate of 10-12 pages long. The process and related forms were far too cumbersome to be used effectively,” adds Noll.

It was Scripps’ auditor that first referred the company to Pinnacle Enterprise Group for guidance in their implementation. Scripps’ preconceptions dictated their initial response when Pinnacle President Kirill Liberman introduced his Lean QMS® to the company. “That would never work here – it’s not complicated enough,” were the kind of comments received from the Scripps team. It took several weeks of consideration while continuing to create volumes of documentation for “this might work” to become an internal directive to utilize Pinnacle’s visual-based Lean QMS® methodology.

Fewer Processes, More Collaboration

The first thing Pinnacle’s Lean QMS® allowed Scripps to do was to discover and understand what the company’s key processes really are. The result allowed Scripps to pare down their processes significantly. They went from 60-70 manufacturing processes to fewer than 10; each with 4-5 discreet functional steps.

Second, the Lean QMS® visual documentation actually gave everyone a real understanding and visibility of the business. By using the Lean QMS® documentation, anyone on the Scripps team could see any process and understand how it relates to the entire business. “The visuals allow you to grasp how the processes interrelate to each other – hard to see in the text version,” comments lab manager Greg Stanton who also serves as the ISO 9001 management representative.

The most important value for Scripps in using the Lean QMS® is found in their improved collaboration. The Lean QMS® gives visibility to process steps that were previously available only to certain individuals.

Many of the Scripps protein purification processes contain manufacturing steps which need to be followed in specific sequences over 3-6 months or longer. Prior to the Lean QMS®, only the person involved or a person with a particular specialty or authorization knew where the products were in the process. This required them to be involved in each step. By using the operational systems developed with the Lean QMS®, including a newly created “smart” numbering system, qualified team members can step in any time to advance the products through the process.

This level of collaboration helps utilize everyone in their most productive capacity. “Everyone in the lab has now become participants rather than observers,” states Lab Manager Stanton.

Now Scripps improvements are not only recorded in the ISO 9001 quality management system documentation, but are actually facilitated by the documentation. The company’s continual improvements grow out of their ability to visualize the business and act efficiently using the information provided through the Lean QMS®. Maintaining ISO 9001 certification is no longer an effort or an objective; it is a byproduct of routine operations.

In reference to Quality Junky, I think that is the sad part about most implementation strategies. Getting certified without having the system be of benefit is no better than any other bureaucratic trap. In looking back at where we were less than 3 years ago to where we are now, I can honestly admit we would not be able to meet our current production requirements if we had not changed our mindset from pre-Pinnacle days.

As always, we are indebted to Kirill and his efforts. Our customers don’t know it but they are indebted as well!

You give me too much credit. I was just the coach that helped get you in shape. You and your team are successfully moving the ISO 9001 ball down the field every day. Not every company (not even every Pinnacle client) runs with the ISO 9001 ball as well as Scripps.

Perhaps you will share how easy your ISO 9001 cetification audit was and how easy your surveillance audits are?

A interesting discussion of ‘the company’s key processes’ so that they discover what “what matters most to who matters most.”

Perhaps this reveals the shortcomings of ISO9001: 2008 and the fact that unlike other popular International Standards like ISO14001: 2004, OHSAS18001: 2007 and FSSC 22000: 2010, the QMS is void of the discussion of identificaiton and prioritization of business risk.

Great and deep point, Rawle. I agree. This is why I have always enjoyed working with you.

I would only add that, in tactical terms, from the standpoint of a company trying to implement a formal QMS for the first time, the shortcomings come from the myths and misconceptions about ISO 9001. This is essentially all a write about.

Unfortunately, most of the myths and misconceptions are propagated by our auditor/consultant colleagues. If more auditors and consultants understood your point, we could all focus on guiding our clients to using ISO 9001 as a true business system platform and management tool. There would be no need to revise ISO 9001 and we could break form the traditional ISO 9001 documentation paradigm.